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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-488 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS

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Page 1: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER: 22-488

ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS

Page 2: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 3: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 4: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 5: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 6: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 7: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 8: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 9: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 10: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 11: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 12: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 13: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 14: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 15: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 16: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 17: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 18: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 19: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 20: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 21: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 22: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 23: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 24: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 25: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 26: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 27: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 28: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 29: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 30: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 31: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 32: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 33: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 34: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 35: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 36: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 37: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 38: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 39: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 40: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 41: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 42: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 43: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 44: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

(b) (4)

Page 45: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 46: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 47: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 48: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

(b) (4)

(b) (4) (b) (4)

Page 49: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 50: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 51: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 52: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 53: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 54: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 55: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 56: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 57: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 58: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 59: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 60: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 61: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 62: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 63: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 64: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 65: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 66: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 67: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 68: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 69: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 70: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 71: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

(b) (4)

Page 72: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

(b) (4)

Page 73: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 74: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

(b) (4)

Page 75: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

(b) (4)

Page 76: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

(b) (4)

Page 77: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 78: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 79: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 80: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 81: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 82: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 83: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Page 84: ADMINISTRATIVE and CORRESPONDENCE …...Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. Analytical Chemist with M.S. and 22 years experience in Drug

Lyrica Oral Solution~Module 1, Section 1.6 Environmental Assessment 24NOV2008

Environmental Assessment

Lyrica Oral Solution(ß

NDA#

20 mg/ml Pregabalin, 16 fl. oz. bottle

This application is for a new oral solution formulation for use in the treatment of all currentlyapproved indications. As this new formulation wil replace usage in the current populationwho has diffculty taking capsules, there wil be no increase in environmental exposure.

Claim for Categorical Exclusion According to 21 CFR Part 25.15 (a),(d)

('-.cDor

Pfizer Inc claims a categorical exclusion to the environmental analysis requirements inaccordance with categorical exclusion criteria 21 CFR Part 25.31 (a): Action on a NDA; ifthe action does not increase the use of the active moiety. Pfizer Inc claims that to the best ofour knowledge no extraordinary circumstances exist.enooN

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Preparer:

Jon F. Ericson, Senior Principal Scientist, Pfizer Global Research and Development,Environmental Sciences, Pharmacokinetics, Dynamics and Metabolism, Groton, CT. AnalyticalChemist with M.S. and 22 years experience in Drug Metabolism and Environmental Science.

The undersigned official states that the information presented is true, accurate, and completeto the best of Pfizer Inc's knowledge.

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ior Prncipal ScientistEnvironmental Sciences! PDMpfzer Global Researh and DevelopmentGrton, cr 06340 USA

PFIZER CONFIDENTIALPage 1 of 1

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CITY OF GroTON BrAND dEVELOPMENT

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S GROTON R ROTON OTON SCHOOL GROTON · PDF fileCurrent Mathematics Teacher Recommendation Current Mathematics Teacher Recommendation 5A GROTON SCHOOL 282 Farmers Row, P.O. TBox 991,

CHAPTER 2 Anatomy/ Pharmacokinetics/Addiction. Pharmacokinetics

Groton Daily Independent

SLIDES: Chelsea Groton Bank and Chelsea Groton Foundation Annual Meeting (4/17/14)